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CPhI-Bericht zeigt Bedarf nach besserer Zertifizierung durch externe Prüfer, um die Wachsamkeit bei GMP zu gewährleisten
Date:7/28/2013

müssen, um den Wert der Qualität hervorzuheben." Qualität kann nicht mehr länger als gegeben angesehen werden und ein unterzeichnetes Dokument ist noch lange keine Garantie", fügte Malhotra hinzu.

Nicht überraschend antworteten 45 % der Befragten auf die Frage, woher die Arznei- und Inhaltsstoffe stammten, mit Indien, gefolgt von 25 % mit China und 19 % mit Europa als führende Lieferanten. Noch interessanter ist, dass 62 % der Befragten erklärten, dass sie sich bei festen Darreichungsformen auf Retard- und Lutschtabletten konzentrierten.  

Chris Kilbee - Konzernleiter, CPhI & Pharma - kommentierte den Erfolg des ersten monatlichen Erkenntnisberichts von CPhI: "Dieser Bericht hat einige wirklich bemerkenswerte Ergebnisse hervorgebracht, die sowohl von den Lieferanten als auch von der Pharmabranche berücksichtigt werden müssen - im Besonderen in Hinblick auf Qualität und Inspektionen, da es in einem globalisierten Geschäftsumfeld unmöglich ist, jedes weltweite Werk für pharmazeutische Inhaltsstoffe zu untersuchen. Daher ist eine unabhängige Zertifizierung ein Muss. Darüber hinaus ist deutlich geworden, dass für Formulierungen für neue Wirkstoffe (NCE - New Chemical Entity) die Bioverfügbarkeit und die Stabilität durch die Verbreitung von komplexeren Wirkstoffzusammensetzungen schwierig zu erreichen sind. Tatsächlich ist es sehr wahrscheinlich, dass mit einer verbesserten Zertifizierung die Pharmabranche auch zunehmend den Entwicklungsprozess auslagern wird und dass durch diesen zunehmenden Wettbewerb Lösungen für Formulierungsprobleme gefunden werden. Zukünftig wird dies Wirkstoffziele ermöglichen, die vorher nicht möglich waren und es werden Neuformulierungen für bereits bestehende Wirkstoffzusammensetzungen entwickelt werden, di
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